EP3006038B1 - Single doses of oritavancin for treating or preventing a bacterial infection - Google Patents

Single doses of oritavancin for treating or preventing a bacterial infection Download PDF

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Publication number
EP3006038B1
EP3006038B1 EP15195726.3A EP15195726A EP3006038B1 EP 3006038 B1 EP3006038 B1 EP 3006038B1 EP 15195726 A EP15195726 A EP 15195726A EP 3006038 B1 EP3006038 B1 EP 3006038B1
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European Patent Office
Prior art keywords
oritavancin
bacterial infection
prophylaxis
subject
staphylococcus aureus
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EP15195726.3A
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German (de)
English (en)
French (fr)
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EP3006038A1 (en
Inventor
Dario Lehoux
Thomas Parr
Gregory Moeck
Pierre Etienne
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Melinta Therapeutics LLC
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Medicines Co
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Application filed by Medicines Co filed Critical Medicines Co
Priority to EP24186111.1A priority Critical patent/EP4464375A3/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

Definitions

  • Oritavancin diphosphate is a semi-synthetic lipoglycopeptide derivative of a naturally occurring glycopeptide. Its structure confers potent antibacterial activity against gram-positive bacteria, including vancomycin-resistant enterococci (VRE), methicillin- and vancomycin-resistant staphylococci, and penicillin-resistant streptococci.
  • VRE vancomycin-resistant enterococci
  • the rapidity of its bactericidal activity against exponentially-growing S. aureus ( ⁇ 3-log reduction within 15 minutes to 2 hours against MSSA, MRSA, and VRSA) is one of the features that distinguishes it from the prototypic glycopeptide vancomycin ( McKay et al., J Antimicrob Chemother. 63(6): 1191-9 (2009), Epub 2009 Apr 15 ).
  • Oritavancin like vancomycin, binds to the Acyl-D-Alanyl-D-Alanine terminus of the peptidoglycan precursor, lipid-bound N-acetyl-glucosamine-N-acetyl-muramic acid-pentapeptide ( Reynolds, Eur J Clin Microbiol Infect Dis 8(11):943-950 (1989 ); Nicas and Allen, Resistance and mechanism of action. In: Nagarajan R, editor. Glycopeptide antibiotics.
  • oritavancin inhibits cell wall biosynthesis even when the substrate is the altered peptidoglycan precursor that is present in VRE and vancomycin-resistant S. aureus (VRSA).
  • oritavancin antibacterial activity extends beyond that of vancomycin to include glycopeptide-resistant enterococci and staphylococci ( Ward et al., Expert Opin Investig Drugs 15:417-429 (2006 ); Scheinfeld, J Drugs Dermatol 6:97-103 (2007 )).
  • Oritavancin also collapses transmembrane potential in gram positive bacteria, leading to rapid killing ( McKay et al., Poster C1-682: Oritavancin disrupts transmembrane potential and membrane integrity concomitantly with cell killing in Staphylococcus aureus and vancomycin-resistant Enterococci. 46th Intersci Conf Antimicro Agents Chemo, San Francisco, CA, Sept. 27-30, 2006 ). These multiple effects contribute to the rapid bactericidal activity of oritavancin.
  • Oritavancin is in clinical development against serious gram-positive infections, where administration of the drug is via intravenous infusion using several dosages administered over a series of days.
  • Mercier & Hrebickova (Expert Review of Anti-Infective Therapy 3(3): 325-332, 2005 ) reviews the efficacy of oritavancin as an antibacterial in various studies.
  • Lee et al. (Surgical Infections 6(3): 283-295, 2005 ) also reviews treatments for cSSSIs, including phase III trials using oritavancin.
  • the development of alternative dosing regimens for the drug could expand treatment options available to physicians.
  • the present invention is directed to oritavancin or compositions containing oritavancin for medical uses in which novel dosing regimens are to be used.
  • the invention provides a pharmaceutical composition comprising oritavancin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent, for use in treating, preventing or providing prophylaxis for a bacterial infection in a subject, wherein said treating, preventing or prophylaxis is by administration of one dose of a therapeutically effective amount of said pharmaceutical composition over a course of therapy, prevention or prophylaxis to a subject having a bacterial infection, at risk of exposure to infectious bacteria, or at risk of developing a bacterial infection, which thereby treats, prevents or provides prophylaxis for said bacterial infection in said subject, wherein said one dose comprises 1200 mg oritavancin, or a pharmaceutically acceptable salt thereof, wherein the bacteria causing the bacterial infection is a bacteria selected from the group consisting of Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, vancomycin-inter
  • the invention provides the use of oritavancin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent in the preparation of a medicament for treating, preventing or providing prophylaxis for a bacterial infection in a subject, wherein said treating, preventing or prophylaxis is by administration of one dose of a therapeutically effective amount of said medicament over a course of therapy, prevention or prophylaxis to a subject having a bacterial infection, at risk of exposure to infectious bacteria, or at risk of developing a bacterial infection, which thereby treats, prevents or provides prophylaxis for said bacterial infection in said subject, wherein said one dose comprises at least 1200 mg oritavancin, or a pharmaceutically acceptable salt thereof wherein the bacteria causing the bacterial infection is a bacteria selected from the group consisting of Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, vancomycin-
  • the pharmaceutical composition comprises 1200 mg oritavancin, or a pharmaceutically acceptable salt thereof.
  • the pharmaceutical composition for use according to the invention is for prevention of a bacterial infection
  • prevention is maintained for at least about 24, 72 or 114 hours.
  • Oritavancin is to be administered in the form of a pharmaceutical composition or medicament comprising oritavancin.
  • Oritavancin may be used per se in the present invention, or in the form of a pharmaceutically acceptable salt, hydrate, solvate, or mixtures thereof.
  • pharmaceutically acceptable salt refers to non-toxic acid addition salts derived from inorganic and organic acids. While reference is made herein to both “oritavancin” and “a pharmaceutically acceptable salt thereof, the term “oritavancin” should be understood to include both the compound per se as well as a pharmaceutically acceptable salt, unless otherwise indicated by context, as the term “oritavancin” alone may be used for the sake of brevity.
  • Acids commonly employed to form acid addition salts are inorganic acids such as hydrochloric acid, hydrobromic acid, hydroiodic acid, sulfuric acid, phosphoric acid, and the like, and organic acids such as p-toluenesulfonic acid, methanesulfonic acid, oxalic acid, p-bromophenylsulfonic acid, carbonic acid, succinic acid, citric acid, benzoic acid, acetic acid, and the like.
  • Base addition salts include those derived from inorganic bases, such as ammonium or alkali or alkaline earth metal hydroxides, carbonates, bicarbonates, and the like.
  • any salt for use according to this invention is not of a critical nature, so long as the salt as a whole is pharmacologically acceptable and as long as the counter-ion does not contribute undesired qualities to the salt as a whole.
  • glycopeptide antibiotics including oritavancin and analogs thereof, may be found, for example, in U.S. Patent No. 5,840,684 .
  • compositions for use according to the invention comprise oritavancin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or excipient.
  • Pharmaceutically acceptable carriers and excipient are those compounds, solutions, substances or materials that can be used to produce formulations of oritavancin that are suitable for administration to a subject, such as a human.
  • carriers and excipients for use in the present invention are those useful in preparing a pharmaceutical composition that is generally safe, non-toxic and neither biologically nor otherwise undesirable, and that may present pharmacologically favorable profiles, and include carriers and excipients that are acceptable for veterinary use as well as human pharmaceutical use.
  • Suitable pharmaceutically acceptable carriers and excipients are well known in art and can be determined by those of skill in the art as the clinical situation warrants. The skilled artisan will understand that diluents are included within the scope of the terms carriers and excipients.
  • suitable carriers and excipients include dextrose, water, glycerol, ethanol, propylene glycol, polysorbate 80 (Tween-80 TM ), poly(ethylene)glycol 300 and 400 (PEG 300 and 400), PEGylated castor oil (e.g. Cremophor EL), poloxamer 407 and 188, a cyclodextrin or a cyclodextrin derivative (including HPCD ((2-hydroxypropyl)-cyclodextrin) and (2-hydroxyethyl)-cyclodextrin; see, e.g., U.S. patent application publication 20060194717 ), hydrophilic and hydrophobic carriers, and combinations thereof.
  • dextrose water, glycerol, ethanol, propylene glycol, polysorbate 80 (Tween-80 TM ), poly(ethylene)glycol 300 and 400 (PEG 300 and 400), PEGylated castor oil (e.g. Cremophor
  • Hydrophobic carriers include, for example, fat emulsions, lipids, PEGylated phospholids, polymer matrices, biocompatible polymers, lipospheres, vesicles, particles, and liposomes.
  • the terms specifically exclude cell culture medium. More particularly: (1) 5% (w/v) dextrose, or (2) water, may be used as a pharmaceutically acceptable carrier.
  • Excipients included in a formulation have different purposes depending, for example on the nature of the drug, and the mode of administration.
  • examples of generally used excipients include, without limitation: stabilizing agents, solubilizing agents and surfactants, buffers, antioxidants and preservatives, tonicity agents, bulking agents, lubricating agents, emulsifiers, suspending or viscosity agents, inert diluents, fillers, disintegrating agents, binding agents, wetting agents, lubricating agents, antibacterials, chelating agents, sweeteners, perfuming agents, flavouring agents, coloring agents, administration aids, and combinations thereof.
  • compositions may contain common carriers and excipients, such as cornstarch or gelatin, lactose, sucrose, microcrystalline cellulose, kaolin, mannitol, dicalcium phosphate, sodium chloride, alginic acid, croscarmellose sodium, and sodium starch glycolate.
  • common carriers and excipients such as cornstarch or gelatin, lactose, sucrose, microcrystalline cellulose, kaolin, mannitol, dicalcium phosphate, sodium chloride, alginic acid, croscarmellose sodium, and sodium starch glycolate.
  • the particular carrier, diluent or excipient used will depend upon the means and purpose for which the active ingredient is being applied.
  • composition compatible excipients also include tonicity agents that make the composition compatible with blood. Tonicity agents are particularly desirable in injectable formulations.
  • compositions for use according to the invention are known to those skilled in the art.
  • pharmaceutical compositions may be prepared following conventional techniques of the pharmaceutical chemist involving steps such as mixing, granulating, and compressing when necessary for tablet forms, or mixing, filling, and dissolving the ingredients as appropriate, to give the desired products for various routes of administration.
  • the present invention facilitates methods comprising contacting bacteria with an effective amount of oritavancin, or a pharmaceutically acceptable salt thereof.
  • the contacting may be carried out in vitro (in biochemical and/or cellular assays), in vivo in a non-human animal, in vivo in mammals, including humans and/or ex vivo (e.g. for sterilization purposes).
  • the term "contacting” is meant to broadly refer to bringing a bacterial cell and a molecule of oritavancin into sufficient proximity such that oritavancin can exert an effect on the bacterial cell.
  • Oritavancin may be transported to the location of the bacterial cell, or oritavancin may be situated in a location to which the bacterial cell travels or is brought into contact.
  • contacting includes physical interaction between oritavancin and a bacterial cell, as well as interactions that do not require physical interaction.
  • a "subject” means an animal, such as a mammal, including humans, other higher primates, lower primates, and animals of veterinary importance, such as dogs, cats, horses, sheep, goats, and cattle and the like, preferably a human.
  • the subject may have a bacterial infection, may be at risk for developing a bacterial infection, or may be at greater risk than the general population for exposure to infectious bacteria.
  • bacterial infection refers to an infection caused by a species or strain of bacteria for which the single dosing methods disclosed herein are appropriate.
  • the pharmaceutical composition (or medicament) for use according to the invention may be used in the treatment of subjects having bacterial skin infections, such as complicated skin and skin structure infections (cSSSI) and complicated and uncomplicated skin and soft tissue infections (SSTI), including abscesses, ulcers, burns and cellulitis.
  • the pharmaceutical composition (or medicament) for use according to the invention may also be used for treatment of deep bacterial infections, such as major abscess, infected ulcer, major burn, or deep and extensive cellulitis.
  • bacterial infections that may be treated according to the present invention include blood stream infections (BSI), catheter-related blood stream infections (CRBSI), osteomyelitis, prosthetic joint infections, pneumonia (community acquired and nosicomial), joint space infections and device infections (e.g., infections associated with pace makers and internal cardiac defibrillators).
  • BSI blood stream infections
  • CBSI catheter-related blood stream infections
  • osteomyelitis osteomyelitis
  • prosthetic joint infections e.g., pneumonia
  • pneumonia community acquired and nosicomial
  • joint space infections e.g., infections associated with pace makers and internal cardiac defibrillators.
  • device infections e.g., infections associated with pace makers and internal cardiac defibrillators.
  • the pharmaceutical composition (or medicament) for use according to the invention can also be used concomitantly with surgical intervention for the bacterial infection.
  • compositions may be used according to the present invention to treat bacterial infections caused by Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, vancomycin-intermediate Staphylococcus aureus, vancomycin hetero-intermediate Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Enterococcus faecalis or vancomycin-resistant Enterococcus faecalis.
  • the pharmaceutical composition (or medicament) for use according to the invention may be used to treat a bacterial infection in a subject.
  • the treatment comprises administering one dose of oritavancin, or a pharmaceutically acceptable salt thereof, formulated as a pharmaceutical composition or medicament, over a course of therapy to a subject.
  • the subject has a bacterial infection, which is treated by administration of oritavancin.
  • the treatment according to the present invention may be based on achieving a particular pharmacokinetic profile for oritavancin in a subject ( Bhavnani et al., Antimicrobial Agents Chemother. 50(3):994-1000 (2006 )).
  • the one dose of oritavancin, or a pharmaceutically acceptable salt thereof, formulated as a pharmaceutical composition may be administered in an amount sufficient to achieve one or more of: (1) a maximum plasma concentration (C max ) of oritavancin of not less than a selected level, or (2) a minimum area under the concentration curve (AUC 0-24hr) of at least a selected level.
  • a therapeutically effective minimum C max of oritavancin will vary based on the concentration of oritavancin in the formulation being administered to a subject, the means of administration, the duration of administration, the type of bacterial infection being treated and the identity of the bacteria in the infection, among other factors such as the physical characteristics of the subject. However, under most circumstances a minimum C max of not less than about 1 ⁇ g/mL should be achieved in a subject. Thus, the treatment according to the present invention may achieve a minimum C max of not less than about 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100 ⁇ g/mL in the subject.
  • the C max of oritavancin is not less than about 20 ⁇ g/mL. In other preferred aspects, the C max of oritavancin is not less than about 40 ⁇ g/mL, 60 ⁇ g/mL, or 80 ⁇ g/mL.
  • the present invention includes achieving a minimum AUC of not less than about 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145 or 150 mg*h/L ⁇ g/mL in the subject.
  • the AUC 0-24hr of oritavancin is at least about 20 mg*h/L ⁇ g/mL.
  • the AUC 0-24hr of oritavancin is at least about 40 mg*h/L/ ⁇ g/mL, 80 mg*h/L ⁇ g/mL, or 120 mg*h/L ⁇ g/mL.
  • the dose contains 1200 mg oritavancin.
  • the dosage may be administered all at once, such as with an oral formulation in a capsule, or slowly over a period of time, such as with an intravenous administration.
  • the administering period can be a matter of minutes, such as about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 or more minutes, or a period of hours, such as about 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 or more hours.
  • the administration of the dose may be interrupted, such as where the dose is administered via intravenous infusion and the dose is divided into two or more infusion bags. Under such circumstances, the administration of the dose may be interrupted while the infusion bags are changed.
  • prophylaxis for bacterial infections may be provided in a subject by administering one dose of oritavancin, or a pharmaceutically acceptable salt thereof, formulated as a pharmaceutical composition (or medicament) over a course of therapy to a subject.
  • the subject is at risk of developing a bacterial infection, and administration of oritavancin provides prophylaxis for a bacterial infection in the subject.
  • the prophylaxis may be about a reduction of at least about 100%, 99%, 98%, 97%, 96%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5% or 1% in the subject, versus a subject to which oritavancin has not been administered.
  • the prophylaxis may last in the subject for at least about 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23 or 24 hours, or 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 or more days after administration of oritavancin.
  • prophylaxis is maintained for the duration of a surgical procedure, a dental procedure or an invasive medical procedure.
  • multiple myeloma, chronic lympocytic leukemia, lymphoma people at increased occupational risk (e.g., public services workers, such a fire, water, sanitary, police, medical, and laboratory workers, hospital workers), people in closed populations (e.g., prisons, military, nursing homes) and others that have immunological deficiencies that might enhance their susceptibility to bacterial infection.
  • the prevention may last in the subject for at least about 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50 or more days after administration of oritavancin.
  • Patients were excluded from the study if they received any systemic antimicrobial agent with gram-positive coverage for more than 24 hours within the 3 days prior to enrollment (unless the gram-positive pathogen was resistant in vitro to the antimicrobial agent or the patient was clinically failing on prior therapy), had a history of severe hypersensitivity reactions to glycopeptides and any of their excipients (patients who had histamine-like infusion reactions to the glycopeptide vancomycin were not excluded) or had an anticipated need for more than 10 days of conventional antibiotic therapy. Pregnant women or women who were nursing were also excluded from the study.
  • Single intravenous doses of ORI 0.5 to 40 mg/kg were tested against one MSSA and one MRSA strain.
  • Efficacy of ORI doses simulating human exposure HEQ doses, i.e. 24h AUC-matched
  • HEQ doses i.e. 24h AUC-matched
  • Both thighs were harvested and CFU counts were evaluated after 24h (single doses) or 72 h (HEQ doses) treatment.
  • the range of doses allowed for a robust assessment of the dose-proportionality (also termed linearity) of the PK of oritavancin. Although a formal statistical assessment of dose-proportionality was not performed, the goodness-of-fit of the final population PK model was used to detect any apparent lack of dose-proportionality.

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EP15195726.3A 2008-08-30 2009-08-29 Single doses of oritavancin for treating or preventing a bacterial infection Active EP3006038B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24186111.1A EP4464375A3 (en) 2008-08-30 2009-08-29 Methods of treatment using single doses of oritavancin

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US9331408P 2008-08-30 2008-08-30
US9349708P 2008-09-02 2008-09-02
EP09810708.9A EP2337575B1 (en) 2008-08-30 2009-08-29 Methods of treatment using single doses of oritavancin
PCT/US2009/055466 WO2010025438A2 (en) 2008-08-30 2009-08-29 Methods of treatment using single doses of oritavancin

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EP09810708.9A Division-Into EP2337575B1 (en) 2008-08-30 2009-08-29 Methods of treatment using single doses of oritavancin
EP09810708.9A Division EP2337575B1 (en) 2008-08-30 2009-08-29 Methods of treatment using single doses of oritavancin

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EP3006038A1 EP3006038A1 (en) 2016-04-13
EP3006038B1 true EP3006038B1 (en) 2024-07-03

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US (2) US8420592B2 (enExample)
EP (3) EP3006038B1 (enExample)
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CN (2) CN102215858A (enExample)
AU (1) AU2009285564B2 (enExample)
CA (1) CA2736860C (enExample)
DK (2) DK2337575T3 (enExample)
EA (1) EA020490B1 (enExample)
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FI (1) FI3006038T3 (enExample)
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NO (1) NO2016019I2 (enExample)
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PT2424559T (pt) 2009-04-28 2024-04-30 Melinta Therapeutics Llc Métodos de tratamento de infeções bacterianas utilizando oritavancina
WO2014031681A1 (en) * 2012-08-20 2014-02-27 The University Of Chicago Inhibiting gram positive bacteria
US20160101148A1 (en) * 2013-04-22 2016-04-14 The Medicines Company Treatment and prevention of bacterial skin infections using oritavancin
US20160206688A1 (en) * 2013-08-26 2016-07-21 The Medicines Company Methods for treating bacteremia and osteomyelitis using oritavancin
WO2015031579A2 (en) * 2013-08-28 2015-03-05 The Medicines Company Methods for treating bacterial infections using oritavancin and polymyxins
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KR20180111948A (ko) * 2016-02-18 2018-10-11 멜린타 테라퓨틱스, 인크. 오리타반신 제제
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CN108409837B (zh) * 2018-03-06 2021-09-24 上海来益生物药物研究开发中心有限责任公司 一组具有抗耐药性细菌活性的糖肽类化合物、其制备方法和应用

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NL300834I2 (enExample) 2016-11-16
EP2337575B1 (en) 2016-04-13
MX2011002249A (es) 2011-06-24
AU2009285564B2 (en) 2014-05-22
HUE027373T2 (hu) 2016-09-28
US8420592B2 (en) 2013-04-16
PL3006038T3 (pl) 2024-11-12
US20130172237A1 (en) 2013-07-04
CN106620649A (zh) 2017-05-10
US20110201546A1 (en) 2011-08-18
WO2010025438A9 (en) 2010-05-14
DK3006038T3 (da) 2024-08-26
JP2012501349A (ja) 2012-01-19
CA2736860A1 (en) 2010-03-04
DK2337575T3 (en) 2016-05-23
CA2736860C (en) 2020-04-28
WO2010025438A2 (en) 2010-03-04
EA201100413A1 (ru) 2012-01-30
AU2009285564A1 (en) 2010-03-04
CN102215858A (zh) 2011-10-12
ES2994966T3 (en) 2025-02-04
NZ591525A (en) 2014-03-28
EP2337575A4 (en) 2012-10-17
EP3006038A1 (en) 2016-04-13
EP2337575A1 (en) 2011-06-29
FI3006038T3 (fi) 2024-08-12
HUS1600039I1 (hu) 2016-11-28
EP4464375A2 (en) 2024-11-20
NO2016019I2 (no) 2019-01-25
PL2337575T3 (pl) 2016-09-30
ES2570401T3 (es) 2016-05-18
JP5782615B2 (ja) 2015-09-24
EP4464375A3 (en) 2025-02-26
NO2016019I1 (no) 2016-10-11
HUE068423T2 (hu) 2024-12-28
PT3006038T (pt) 2024-08-23

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